Clinical Use of EVUSHELD as Pre-exposure Prophylaxis in Real-world Setting in Gulf Cooperation Council Countries

AstraZeneca550 enrolled

Overview

Study on Clinical Use of EVUSHELD (AZD7442) as Pre-exposure Prophylaxis in the Real-world Setting - A Multi-Centre Observational Prospective Study to Determine the Utilization and Clinical Outcomes of EVUSHELD in Gulf Cooperation Council Countries

Study on Clinical use of EVUSHELD (AZD7442) as pre-exposure prophylaxis in the Real-world Setting Observational Prospective Study to determine the utilization and Clinical Outcomes of EVUSHELD in GCC. This will be a multi-country, multi-centre, single-arm, observational, prospective study using primary data collection to describe the demographic and clinical characteristics of patients who received the first dose of AZD7442 for the prevention of SARS-CoV-2 infection causing symptomatic COVID-19 illness. The study will be conducted in the hospital/centers that are authorized to administer AZD7442, agree to participate in the study, and wherein investigators have access to all medical records (electronic/paper) for individual patients. The physicians at the hospital/centers will make a decision to administer AZD7442 to patients according to the local regulations (including the prescribing information) and such a decision to use AZD7442 is independent of the study.

Study Type

OBSERVATIONAL

Enrollment

550

Conditions

COVID-19

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Individuals receiving their first dose of AZD7442 for the prevention of SARS-CoV-2 infection within the 30 days prior to study enrolment. * The ability or willingness to sign informed consent/assent forms Exclusion Criteria: * Patients currently participating in interventional clinical trials of SARS-CoV-2 vaccines, other SARS-CoV-2 prophylactic interventions, or COVID-19 treatments. * Patients with an ongoing COVID-19 infection at the time of AZD7442 administration as judged by the study physician.

Locations (2)

Research Site

Abu Dhabi, United Arab Emirates

Research Site

Dubai, United Arab Emirates

Outcomes

Primary Outcomes

Demographics

To describe the baseline demographic of individuals receiving AZD7442 for pre-exposure prophylaxis

Time frame: 12 month

clinical characteristics

To describe the clinical characteristics of individuals receiving AZD7442 for pre-exposure prophylaxis

Time frame: 12 month

baseline and repeat administration

To describe the baseline and repeat administration(s) of AZD7442 for prevention of SARS-CoV-2 infection

Time frame: 12 month

Secondary Outcomes

Incidence of SARS-CoV-2 infection

To describe the incidence of SARS-CoV-2 infection (asymptomatic or symptomatic), medically attended COVID-19, and COVID-19 related hospitalization and death up to 12 months after administration of AZD7442 for prevention of SARS-CoV-2 infection

Time frame: 12 Month

Incidence of all-cause hospitalization and mortality

To describe the incidence of all-cause hospitalization and mortality during the 12 months after administration of AZD7442 for prevention of SAR-CoV-2 infection

Time frame: 12 Month

COVID-19 risk behavior at time of AZD7442

To describe COVID-19 risk behavior at the time of AZD7442 injection and during the 12 months after first administration of AZD7442 for prevention of SARS-CoV-2 infection

Time frame: 12 Month

Describe health-related quality of life

To describe health-related quality of life (QoL) at the time of AZD7442 first injection and during the 12 months after first administration of AZD7442 for prevention of SARS-CoV-2 infection

Data from ClinicalTrials.gov

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